MAUDE Adverse Event Report: STAAR SURGICAL COMPANY EVO/EVO+ VISIAN IMPLANTABLE COLLAMER LENS; PHAKIC TORIC INTRAOCULAR LENS

Model Number	VTICMO 12.6 (-16.00/+3.5)
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cataract (1766)
Date of Event	05/02/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6- investigation type code: 4110- lens work order search-no similar complaint event(s) within associated lots were found.H11- manufacturer narrative: cataract and secondary surgical intervention to remove/replace/reposition the lens is identified in the labeling as a known potential adverse event following icl implantation.Claim# (b)(4).
Event or Problem Description
A facility representative reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced a lens rotation not associated with low vault and a lens opacity (asc) was observed.The lens was repositioned but that did not resolve the problem.In a separate surgery, the lens was exchanged with the same model, longer length and the problem was resolved.The cause of the event was reported as other and the device did not fail to perform as intended.
Additional Manufacturer Narrative
Device evaluation: h3 - type of investigation code: 10- device evaluation: the lens was returned in liquid in a microcentrifuge vial.Visual inspection found haptic broken.Dimensional inspection found the lens to be within specifications.Corrected data: b5.- a facility representative reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced a lens rotation not associated with low vault and a lens opacity (asc) was observed.The lens was repositioned but that did not resolve the problem.In a separate surgery, the lens was explanted.Reportedly, "currently the icl lens has been explant and the doctor is planned to be replaced with a larger size from size 12.6 to size 13.2.For new lens implantation waiting for doctor's schedule because currently on leave for overseas travel.H6.- health effect - impact code (f): 4629 should be removed and 4627 should be added.Claim# (b)(4).

• Brand Name: EVO/EVO+ VISIAN IMPLANTABLE COLLAMER LENS
• Common Device Name: PHAKIC TORIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer (Section G): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene enriquez ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 22063530
• Report Number: 2023826-2025-00728
• Device Sequence Number: 20910025
• Product Code: QCB
• UDI-Device Identifier: 00840311324224
• UDI-Public: (01)00840311324224(11)230308(17)260228
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2026
• Device Model Number: VTICMO 12.6 (-16.00/+3.5)
• Device Catalogue Number: VTICMO 12.6
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2025
• Supplement Date Received by Manufacturer: 08/18/2025
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTRIDGE MODEL-SFC-45, LOT#-1791612.; FOAM TIP PLUNGER MODEL-FTP, LOT#-1791603.; INJECTOR MODEL-MSI-PF, LOT#-1583699.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 43 YR
• Patient Sex: Male